The present invention relates to packaging materials for medical devices. More specifically, it relates to separate protective liners for medical device containers which are commonly employed to protect the device from shock and abrasion during handling. These liners, which may be particularly suitable for sterile packaging of devices, also protect the container from damage from the medical device that would result in a breach of the sterile environment inside the container.
It is important for medical containers, as well as protective liners, to be easy to open and handle for gloved individuals, such as surgical staff. After having been opened, liners and other packaging materials may typically be discarded. Being disposable, as well as being manufactured in large quantities, these protective liners must also be inexpensive and easily assembled.
The medical field has attempted to provide these functions and features in various ways. One such example is to place a medical device into a foam envelope. The device and envelope are next placed into a container forming a snug fit between the envelope and container to immobilize the device. Finally, a cover is placed on the container and the container and cove are moved into a machine that applies heat and pressure to seal the cover in place. To facilitate sealing, the device and foam envelope must not protrude above the rim of the container. In use, the cover is peeled from the container within an operating room and the product and envelope are removed. This can be difficult due to the snug fit of the envelope in the container; difficulty in removal of the device can lead to dropping or otherwise contaminating it, thereby rendering it useless. After removal from the container, the envelope is carefully removed from the device, requiring more handling.
To simplify device removal, an alternate liner is sometimes used. This alternative comprises a box-shaped foam liner, either a one-piece unit or a more economical die cut foldable unit, that conforms to the shape of the container. This type of conforming liner does not cling to the device like an envelope, and therefore eases removal of the device therefrom. However, the conforming liner preferably must be provided with a lid and a means to securely close the lid so as to avoid interference with the sealing process. In U.S. Pat. No. 4,750,619, Cohen et al. shows a die cut liner of this sort. Cohen's liner comprises a bottom with integral side and end walls and a lid extending from one of the end walls such that the liner is foldable into a box shape with the lid coming to rest atop the walls. Cohen further provides a tray to enclose the liner, the tray including hinged leaves that maintain the liner in a closed position when the tray and liner are placed in the container. It can be seen that this more complicated arrangement requires an additional component, namely the tray, and subsequently additional cost to confine the liner. Additionally, the tray and liner must be removed from the container to access the device which requires the troublesome handling of several package components.